Clinical Data Specialist

Experience : 5+ yrs

Work Mode : Work from Office

Work Location : Bangalore

LOOKING FOR IMMEDIATE JOINERS ONLY

Job Description - Clinical Data Manager :

OVERVIEW

The Clinical Data Manager (CDM) is an independent role responsible for supporting the study team and developing comprehensive study documentation, designing database specifications, and overseeing validation, maintenance / data cleaning, and closeout activities for clinical trial databases. The CDM is recognized as the platform expert, leveraging cutting-edge tools and technologies to provide continuous data insights and ensure the timely delivery of high-quality results for Sponsors. The CDM has a strong foundation in clinical data management, combined with the agility to adapt as processes evolve towards the integration of clinical data science.

KEY TASKS & RESPONSIBILITIES

• Define project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design and Data Review and Data Reconciliation tools.
• Understand external data collection, its integration into the clinical trial, and the management and reconciliation processes required to ensure its accuracy and relevance.
• Execute data cleaning strategies to accelerate the time to achieve subject data cleanliness and ensure high-quality, timely deliverables.
• Perform holistic data review and trending analysis via reporting and elluminate® analytics to proactively identify issue, risks and develop mitigation strategies.
• Utilize artificial intelligence (AI) and machine learning (ML) for anomaly and outlier detection to enhance the efficiency and quality of trial data.
• Monitor and interpret key performance indicators (KPIs), metrics, dashboards, Clinical Trial Operational Analytics (CTOA), and reports to provide actionable recommendations to study lead(s) / project manager.
• Perform Query Management
• Define specifications and collaborate with technical team on configuration of centralized data management platform, elluminate® Data Central for data cleaning strategy and oversight activities.
• Prepare and maintain data management documentation (e.G., DMP, CCGs, Help Text, DVS) and update throughout trial lifecycle.
• Review and ensure the quality control of team-developed deliverables, covering eCRFs, study documents, program / report specifications, outputs, and elluminate® Data Central with analytics modules. Actively evaluate and contribute to enhance processes to increase efficiency and effectiveness.
• Collaborate and work as a team to ensure the deliverables are completed on time with high quality.
• Ensure compliance with industry quality standards, regulations, guidelines, and procedures.
• Other duties as assigned.

CANDIDATE’S PROFILE :

Education & Experience

Professional Skills

Technical Skills